Sydney: 31st March 2015

As with the Canberra Hearing, what follows is a sketch based on the verbatim transcription by Hansard of the day’s proceedings in Sydney. For a far more in-depth and detailed understanding of what occurred, reading the document in full is recommended. It can be downloaded here.

The day in Canberra had largely been one to flesh out the arguments against the Regulator of Medicinal Cannabis Bill which would have created a national, single-purpose, stand-alone body to watch over everything to do with the plant and its medical use.

Sydney though was another matter. With just one exception, it was as if those representing the entire pro-lobby had been gathered under one roof to have their say and get the thing out of their systems. Medics, academics, medical cannabis users – some of them hardened campaigners – enthusiastic advocates of the drug and what it could do lined up to make their case. So compelling was some of the evidence, one among a quartet from the Senate’s Legal and Constitutional Affairs Legislation Committee, Senator Barry O’Sullivan (Qld.) was moved to exclaim ‘shame on us if we do not sort this out pretty quickly for these people‘ and ‘if there is an urgency, it is for us to very quickly make sure there is a pathway for R&D. We should be able to solve that by the time the sun sets today, in effect, as a challenge, before we start to produce and particularly before we start to have clinical trials that involve people.’

It didn’t, of course, come to pass.

Many suns have set since then with medical cannabis users not that much better off than they were pre-2014. Not noticeably anyway. But the sentiment was doubtless meant well.

Ranged against the naysayers heard from the previous day were what one might call the ‘rockstars’ of the national cannabis dialogue. Lucy Haslam was there, whose story – with son Dan and husband Lou – had brought the debate to the stage. And Laurie Mather, a ‘medical scientist with over four decades of research and teaching experience in the fields of applied chemistry, pharmacology, biopharmaceutics and therapeutics in Australia and overseas‘. His arguments would go shoulder to shoulder with those of equally expert researchers like Sydney University’s David Allsop, Nick Lintzeris and Iain McGregor – a Research Fellow ‘heavily embedded in the area of cannabinoid research for 20 years with more than 40 publications looking at the cannabinoid system‘. Then Alex Wodak, the noted physician, 30-year director of the alcohol and drug service at St Vincent’s Hospital, Sydney, now retired and volunteering full time on drug law reform in Australia. It was quite an ensemble with headlines a-plenty forthcoming.

Who could miss – or would want to – the refined and genteel (occasionally less than genteel) aspersions cast at medical cannabis doubters and other such apostates?

Professor Mather’s side-swipe at the ‘many people’ who, either because of ‘ignorance’, ‘laziness’, ‘naively or intentionally’ wanted to prevaricate on evidence ‘or really have other motives’ in denying the the strength of the case for the medical herb was one of these. Are you listening you people? You know who you are…

The four politicians it seemed were, if Sen. O’Sullivans comments might be used as a measure.

And what about Mrs Haslam and her exposition about Drug Free Australia and their cronies at Family Voice? The lobby groups, largely informed by a born-again Christian morality whether or not they admit it, had predictably opposed the Bill. Shocking are not Mrs Haslam’s remarks but what those organisations had done to deserve them. The exchange on this between herself and Senator Ricahrd Di Natatale, the Bill’s Sponsor, who’d made his way from the previous day’s Canberra hearing, is riveting and bears reproduction in full:

Sen. Di Natale: (The Australian Capital Territory were yesterday holding their own public inquiry about medical cannabis and) Drug Free Australia presented at that hearing. Are you aware of that, and are you aware of how they referred to you?Mrs Haslam: No, I am not.Senator Di Natale: It was reported in the paper. They said that your story was just a medical showcase.Mrs Haslam: Can I just say that when I held the medicinal cannabis symposium in Tamworth in November last year, which was done purely because I saw there needs to be education and it was just my way of bringing people to Australia to provide education, Drug Free Australia put out a media release the day before absolutely denigrating the symposium and saying that I had some person there—I cannot even remember the person’s name — that I had brought over from America to tout recreational drug use. I have never even heard of the person. They just filled this media release of absolute lies. So I do not think a lot of Drug Free Australia. I think they are alarmist. I think they are dangerous and I think they have got it completely wrong. I have got nothing to gain out of this except seeing people suffer less, and unless Drug Free Australia have a son that has gone through what we went through, they do not get it. They are never going to get it. People with closed minds should have closed mouths, and I am afraid they are in that bucket’.

So much for that lot. But it got worse, as the bench was soon to discover. Mrs Haslam continued:

‘There is another group called Family Voice Australia. I had a mother contact me from Victoria who was one of the first mothers to treat her child with medicinal cannabis. I think that child is something like 18 months seizure free now, and she was going from having 300 seizures a day. She is 18 months seizure free. This mother called me to say, ‘Lucy, are you aware that Daniel’s photograph is on a pamphlet that my kids came home from school with today from a group called Family Voice Australia saying how he is encouraging people to use cannabis.’ Anyway, she sent that to me, and I hit the roof. We rang them straightaway and said, ‘What are you talking about? Where are you getting this information?’ The take on the publication was that Dan Haslam might have cancer but he just wants to get high, basically. So we spoke to them. I asked them where they got their information from. They basically did no research whatsoever. They had picked his photograph off the internet. They had no consent for anything. We wrote to them. We asked for a complete retraction, which I am sure we never got. My Daniel did not swear very much, but I can tell you now he swore to that lady on the telephone, and if he had not done it I would have. But that is what these ultraconservative groups are trying to do. They are trying to make us look bad when we are only trying to support people that we have seen are clearly benefitting’.

‘That was as good a response as I have ever heard to those people,’ Sen. Di Natale concluded.

The meat of the debate though was quieter but for that still no less dramatic.

Medical cannabis, said Professor McGregor, offered, a ‘very exciting new frontier in pharmacology and therapeutics that has undergone remarkable scientific evolution over the past 20 years. Our bodies and our brains are marinated in cannabis-like molecules which we call endocannabinoids. We are now learning that CBD has incredible therapeutic applications. In a major clinical trial in Germany, it was shown to be as effective as standard antipsychotic medications in the control of schizophrenia.’

It was one though that had on occasion sent him ‘walking out of the lab and wanting to hang up my coat and not try any more. It is just so hard….Research in this domain has been held up over the last two decades by regulatory frameworks,’ although ‘changes are happening all over the place in the rest of the world. They are starting to line up to reap the benefits of these changes. It would be a real shame if Australia was not part of that process early on.’

The University’s Professor Nick Lintzeris, who is also Director of Drug and Alcohol Services at South East Sydney Local Health District, took up the cudgel – he, as well as Professor McGregor – was concerned that research was being hobbled by regulation, that the law had not kept up with science. On that the boffins were one.

‘The cutting-edge science is not so much looking at the therapeutic roles of THC,’ he said, ‘but looking at some of the other cannabinoids and in many respects looking at what has been described as the ensemble effect — so looking at mixtures of the different cannabinoids. That appears to be where a lot of the interest is and a lot of the exciting work.’

And the Bill, he thought, ‘strikes a good balance between the alternatives of decriminalisation which probably wouldn’t be useful for research and existing tight controls which hinder it‘.

It was though, he felt, an alternative to the TGA system. The TGA had not put cannabis on the agenda and was being ‘pushed in from external sources. They seem to be responding on the backfoot to the growing science of medical cannabis. An office of medicinal cannabis would allow us to regulate the manufacture and distribution, provide protections for those concerned. Once you have such mechanisms in place, then you can do a lot of the other translational work such as consumer education and health professional education‘.

He gave a quick history lesson in which poppies and Australia’s $ multi-million trade in them would enter the fray, as they had done in Canberra a day earlier.

Hemp manufacturers, he said could switch over to medical cannabis ‘this year’ but regulatory frameworks prevented it, because though poppies were bred in Australia ‘farmers currently just grow and ship raw product – sell things to people overseas who do the value adding’. And cannabis would require different handling, yet ‘no-one even debates whether there should be use of medicinal opioids. That is largely because we have 150 years of pharmaceutical development of them. Two hundred years ago, cannabis was one of the most widely prescribed medications in the doctor’s kit in Western medicine. Let’s be very clear. Will there be a medicinal cannabinoid industry moving forward? The science is telling us, ‘Yes, there will be and there already is.’

So what then was the big hold up?

‘I guess you could pick on the 1961 UN Single Convention. THC had not been discovered when they prohibited cannabis under that Convention. Then in the 1990s we learned about the endocannabinoid system. Recent developments in this area have been immense, but the 1961 Single Convention still rules the roost to acertain extent.’

But the Professor surely nailed it when he went on to describe the two main medical cannabis ‘factions’. ‘At one extreme,’ he said, ‘there were those who thought ‘this is better than sliced bread and should be in the drinking water’ and, at the other ‘people who say the evidence is not there and we really should not be progressing, it is too risky and, for a range of reasons, we do not want to go down that track.’ What was required was ‘a fine balance about how governments, professional societies, regulators and consumer groups keep abreast of the evidence and make sure – where we know there is a role for the cannabinoids and they can be provided safely – those markets are then opened up.’

Which a ‘savvy Regulator’ – as was being proposed by the Bill and one that could see the potential – might be able to do.

Emeritus Professor Mather’s turn now, and he wasn’t messing about.

‘It is common for detractors,’ he began, ‘to claim there is not enough evidence or that the evidence is weak or that there are already sufficient drugs that cater for the pharmacotherapy afforded by cannabis. I maintain otherwise. Moreover, I venture to add that there are many drugs in current use, including some supported by the PBS listing, for which the evidence of therapeutic efficacy and safety is not as strong as that for cannabis, even allowing for inconsistencies in the cannabis products used’.

Ouch.

But why was that then? Well, it was simple enough…..

‘Over many decades, people engaged in politics and the law have essentially decided that cannabis has no therapeutic value, despite the evidence provided by people with medicinal and scientific expertise that it does.’

And this had meant:

‘Resources associated with cannabis have been directed in abundance towards law enforcement and societal dissuasion. Similarly, research of its harms from its non-medical use has been promoted whilst research of its medicinal use has been thwarted.’

There in a nutshell, from the gentleman in the white coat.

Bit of a problem though. While ‘there remains the strong possibility that selective preparations of cannabis could become first-line pharmacotherapy for certain conditions within the near future, when used as a medicine, it cannot be regarded as a single drug, and therein lies an issue. Conventional regulatory bodies have no framework for examination and approval of potentially variable mixes of drugs. Conventional pharmaceutical companies have little to gain from investing in natural products that cannot be patented or bear an illegal drug label.’

Oh dear. So what then was likely to happen?

‘We are likely to see yet another dog’s breakfast of all kinds of legislation on what is permitted and what is not permitted, and so patients and researchers and others will fall foul, I believe, of this inconsistency of regulations‘.

And this despite peer reviewed trials and reviews outside ‘the anecdotal literature’ which ‘in terms of percentage or proportionality…is pretty convincing that cannabis has beneficial effects’.

Ms Ireland went first, laying out the position for some epilepsy patients, their carers and the problems they faced using cannabis.

She was speaking, she said, ‘as a representative of consumers living with intractable epilepsy or medication resistant epilepsy,’ and explained to Committee members around 30 per cent of those suffering with the condition were likely to gain reasonable seizure control leaving 30 per cent that would not, thus finding themselves forced to live with the impact of frequent, in some cases daily, seizures.

‘They,’ she said, ‘are the people we can represent. And many are expressing concern about accessing medicinal cannabis within the framework of the current Australian system.’

Vulnerable to prosecution, there had been anecdotal threats of possible removal of children from their parents’ care for using the drug; some families had being told their child had a limited time to live. Her organisation, she said, would welcome a Regulator that provided a framework to access a sustainable supply of the medicinal drug and consideration of the practical aspects of daily life for authorised patients and carers. Medical oversight too of prescribing, titration and monitoring of it would be equally welcomed, and, somehow, the provision of affordable access preferably through the Pharmaceutical Benefits Scheme plus inclusion of whole of plant extracts in the definition of ‘medicinal cannabis’.

Maybe one day.

But these were desperate people. For those whose children suffered sometimes scores of seizures a day and for whom conventional medicine had failed, what then?

Child services had sometimes stepped in as result of parents giving their children the drug. This risked the child being removed from the home and the cannabis removed from the child – in turn leading to more seizures putting them at extremely high risk of death.

True, there was the possibility of only hearing from those for whom cannabis worked by relying on anecdotal evidence, but families – some at least – were in need of immediate help. Some, along with specialist suppliers had been or were being prosecuted.

But ‘Orrin Devinsky, a renowned child neurologist based in New York research into children with Dravet Syndrome using cannabis syndrome. Fifty-five per cent of the children improved.‘ Ms Todd told the panel.

But on it went, a litany of legal insanity. Child Services. Possible or actual arrest. State and Federal laws and regulations.

‘The first parents who started coming out and saying, ‘We are trying this, and look at these amazing results,’ were the ones who were told that their child was having so many seizures that they would have only a few months to live. That is where it started. Now it is starting to spread to families who are in very similar situations but before they are being told that their child only has a couple of months to live because of the seizure activity,’ Ms Todd explained. It was no wonder the Senators were getting on side.

Mr Feeney came straight to the point. A significant proportion of the estimated 26,800 people with HIV in Australia live with a burden of disease that goes beyond the HIV infection itself. HIV Futures Seven, the national cross-sectional survey of 1,058 HIV positive Australians, reported people with the virus continue to experience higher rates of multimorbidity, and about a fifth used cannabis for therapeutic and symptom relief.

In the previous 12 months, a response to the survey showed 25 per cent of them had peripheral neuropathy; 35 percent nausea and vomiting; 62 per cent diarrhoea; 63 per cent sleep disorders; 28 per cent weight loss and 80 percent low energy and fatigue. And cannabis could help with them all.

Therefore ‘decriminalisation of cannabis cultivation and possession for medicinal use would allow people with HIV to have more control and choice over strength, purity and availability. A quarter of people with HIV live below the poverty line, and the cost of cannabis can be and is an issue.’

Turning to Ms Todd and Ms Ireland, Sen. Di Natale pondered: ‘Say we had a bill that says: ‘We recognise there are people who are using this at the moment. We have an opportunity to produce a product of known quantity and quality, and we know exactly what proportion of CBD to THC is in that product. We can do it in a controlled environment where we can actually research it. We might do a trial that looks at comparing different groups and sees that we are using it for the same conditions, comparing like with like’. As you said, there are many variations of epilepsy. How would you feel as an organisation if we had a legislation framework set up that said, ‘Now we can allow your consumers access to a drug of known quality and purity under controlled conditions, and we can have all the symptoms documented and build the research base that we need to to decide whether or not this is an effective therapy’?

No guesses as to the answer, but such a Bill was never to be.

Senator Ann Urquart, from Tasmaina and a Co-Sponsor of the Bill had a statement.

‘In Tasmania’, she said, ‘I have met many, many parents who administer medicinal cannabis to their children. To hear their stories but to also look at the photos of what their child was like when they were on drugs that did not particularly work for their seizures and to see the children now—some are young adults but others are still quite small children—demonstrates that it is absolutely life changing, not only for the child but also for the parents, who can now generally go about their day.’

As a result of such evidence, the Senate Committee was to recommend the Bill find its way into law.

As a result of what had been said in Canberra, the Government was to reject that suggestion.

Lucy Haslam was next on the stand. And like Professor Mather before her, she had no plans to mince words – her opening statement a damning indictment of the system that had made her an outlaw. Beside her, Sally Crossing, Convener of Cancer Voices Australia and no less a proponent of cannabis.

‘The fact that medicines are approved for use by the TGA does not make them safe,’ Mrs Haslam began. ‘Dan, my son, was prescribed and became heavily addicted to opiates and benzodiazepines during his cancer treatment. These drugs were prescribed very liberally and without adequate consultation regarding the harms. Ironically, this type of medical practice is considered acceptable. By contrast, the side effects of cannabis were far more manageable and the benefits were enormous, yet we were criminalised for using this safer and more effective medicine.’

The panel would be in for ride.

‘The double standards reflected by Australian laws make it a mockery,’ she continued. ‘Historical negativity by the government and by the medical profession has been adversely impacting patients who deserve to be supported. The result has been widespread civil disobedience by good people. Education changes conservative minds’.

Well, sometimes maybe. But didn’t someone once say people don’t want the truth, they only want reassurance what they believe is the truth? Didn’t someone say that?

Her son’s suffering she went on, was being experienced behind closed doors in thousands of households.

Yet, quoting Harvard Professor Lester Grinspoon, ‘cannabis will one day be seen as a wonder drug, as was penicillin in the 1940s. Like penicillin, herbal marijuana is remarkably nontoxic, has a wide range of therapeutic applications and would be quite inexpensive if it were legal …‘

Ms Crossing joined in. Her organisation had long supported legislative change to enable access to medical cannabis under sensible safeguards and fully supported the need for a Regulator as proposed by the Bill, noting that it covered a much wider field and did not impinge on TGA presses.

There was a situation that needed to be fixed said Mrs Haslam, and was asked to recount Dan’s and the family’s story.

Though extremely well known, it’s worth repeating it here, in Mrs Haslam’s own words:

‘Daniel was diagnosed with stage 4 bowel cancer when he was 20. He had three years of treatment, which involved a lot of major surgeries but also a lot of chemotherapy. He was three years into chemotherapy and he was told basically that for as long as he lived he would require chemotherapy.

But for him chemotherapy was not just something that you slotted into your routine; it was a major issue for our whole family because he became so violently ill from the chemotherapy. Daniel developed what is called anticipatory nausea, which is quite common in young people who are on very strong chemotherapy. Just the thought of chemotherapy would actually make him vomit. So, the day before chemotherapy, he would start being unwell. He would initiate all sorts of stalling tactics on the day of chemotherapy, because he would start vomiting, and he would usually vomit on the way to chemotherapy. He would vomit all through chemotherapy. He would vomit on the way home. And usually, invariably by midnight that night, after hours of vomiting, it would be an emergency trip to Accident and Emergency to have some fluids and to have more IV anti-emetics. He tried literally every anti-emetic that was available pharmaceutically, even the ones that were classed as the Holy Grail, like Aloxi and Emend, which were better than the rest. They worked to a degree, but this became such a psychological issue as well—a bit like Pavlov’s dog, I guess. We tried to seek help for this in all number of ways, and nobody really was equipped to help us deal with it.

At the point where Daniel tried cannabis, he was three years into this treatment. The chemotherapy was not working. They were saying he needed to go back to the original chemotherapies they had tried, which didn’t last very long with him because the side effects were so severe. A local Tamworth businessman friend of Daniel’s because he had been through bowel cancer two years prior, and he eventually said to Daniel: ‘Look, Dan, this is no way to live. I’ve got some leftover cannabis that my partner got for me when I was having chemo. I want you to try it.’ Daniel said: ‘No, I can’t do that. Mum and Dad would be against that. Dad’s spent his life locking people up for illicit drug use. I can’t do it.’ That friend then rang me and said, ‘Look, Lucy, don’t think I’m a drug pusher or anything, but I think Dan needs to try cannabis,’ and I said, ‘Yes, please, bring it round.’ We were so desperate. It was one of the most soul-destroying things to watch him every fortnight go through this whole process, and it was unrelenting. So we clutched at it with, ‘Yes, bring it round.’

The next time Daniel had chemotherapy, my husband was at work, and I remember that Dan sent him a text: ‘Dad, come and do your thing.’ Dad came round and taught Dan how to roll a joint. He had been undercover in the drug squad for many years of his career. Even though he was a nonsmoker, he had that history, so he rolled Dan a joint. Dan had a couple of puffs. He was a nonsmoker, so that was difficult for him, but he had a couple of puffs on a cannabis joint, and it was amazing. I really cannot understate that. It was as near to a miracle as I have ever seen. He would come home with a chemotherapy pump on, so he would be out of the clinic but effectively still hooked up to chemotherapy, and he would be the colour of that (white) cup for days. He had a couple of drags; the colour came back into his face, and he just went: ‘Wow! I’m hungry. Mum, can I have something to eat?’ We just went: ‘What is going on here? This has never happened’—because this kid would lie in a hospital room for days and days not eating. This was just such an incredible change. It was life-changing for all of us. We just looked at each other and thought, ‘Well, if this is what it takes, this is what it takes.’

Feeling very exposed because of the need to buy larger quantities of the drug – ‘which would have had me locked up very quick smart‘ – the family went public ‘because I did not feel it was right that you should be criminalised just for wanting to live.’

‘Everything about this Bill is right‘, Mrs Haslam was resolute. ‘It is absolutely the way we should go.’ But action was needed right now.

‘We cannot afford to wait for the results of clinical trials, which everybody knows take a long time. Yes, they are valuable. But we should be looking at patients and supporting patients that are using it now,’ she insisted, raising the sore point of establishment sceptics, her affront at them unmistakable.

On the conservative element within medicine she was scathing: ‘There are,’ she said, ‘diverse opinions among the medical and scientific fraternity. For a long time that’s held things back. Some conservative medical practitioners make some very generalised and sweeping statements that are negative and detrimental. Overwhelmingly, people have dismissed anecdotal evidence as almost being a lie but I lived the experience. I know it got his head out of a toilet. I don’t care if it is anecdotal. If it were a court of law and someone had witnessed something firsthand, that would be the strongest form of evidence. Yet in the medical field the idea of something being anecdotal is almost dismissed. If someone is getting relief from medical cannabis, they are getting relief from medical cannabis. Does it matter that there aren’t umpteen clinical trials that are current and conducted in this country to back it up? If someone with a terminal illness says that their pain is less, they sleep better, they do not have massive mouth ulcers, they do not spend their fortnight throwing up, what are we worried about? The long-term side effects of using medicinal cannabis are completely irrelevant to that person, yet that has been the message of some in the medical fraternity: that we have to be concerned about psychotic episodes that might happen long into the future.’

Difficult to fault that kind of logic.

Added to the desperation felt and expressed by witnesses speaking on behalf of epilepsy sufferers and the expert opinions of some of the country’s most distinguished thinkers and researchers on the matter it was hardly surprising the Senate Committee recommended the Bill be enacted. The testimonies the bench had been privy to had been a collective tour de force.

All three were, they said, in favour of more research. Given the available evidence, cannabis, they thought, could provide benefits. Possibly. And they quite liked the idea of compassionate schemes for medical cannabis users. Potentially. They didn’t endorse smoking it though, and – where MS was concerned – the organisations involved had found around 10 per cent of sufferers believed the drug might improve their condition. Sativex – the only cannabis-based product approved in Australia – had been shown in clinical trials to ease the muscle spasticity associated with MS and had been approved by the TGA specifically for that purpose. But the current regulatory framework meant it was unavailable to people because of its Scheduling.

By November 2016, this, at least, to some extent has been fixed.

All supported the idea of a single, national regulator as had been proposed by the Bill – another slash across Sen. Di Natale’s five-bar-gate.

Next came another Professor – by now surely enough for a faculty. Alison Ritter, Director of the Drug Policy Modelling Program at the Government’s main drug-policy think-tank the National Drug and Alcohol Research Centre at New South Wales University was there, she said, to offer technical suggestions about how the Bill might be implemented. Her organisation had previously made an exhaustive Submission to the Inquiry – Framing the Regulatory Options – which, Prof. Ritter told the panel, had encompassed a whole variety of critical issues that she proposed to run through today.

Which she did, and which you can examine if you read the submission. She also, notably pointed out the unique position of the drug, largely because of its reputational impedimenta.

The problem with cannabis, she said, ‘is that it is cannabis, which has this long, social and political history about being an illegal drug that is dangerous, that is associated with pleasure. For goodness sake! That is awful! We cannot have any of that! It carries this enormous baggage. Here we are trying to design a scheme for people with medical conditions, when we are up against an object – ‘cannabis’ – that has all of this very difficult history associated with it’.

To which few could take exception.

Prof. Ritter was followed by another blaze in the cannabis firmament – Dr Alex Wodak, mentioned before in this piece. Together with his friend Mr Ben Mostyn, he would be giving the take not just of the Australian Drug Law Reform Initiative, which Mr Mostyn co-founded and of which both were members, but that of a doctor with decades of first hand experience in the field of alcohol and drugs, most of it at at senior level.

Four areas were relevant, he thought, to medicinal cannabis use in Australia, those being effectiveness, safety; cost effectiveness and lastly, maintaining the integrity the existing regulatory system — that, of course, being the TGA.

Though not necessarily a curative, cannabis, he opined, could help with a number of symptoms.

And at this he fell back on Hippocrates, telling the panel doctors should ‘cure sometimes, treat often and comfort always‘. His presentation, he said, would be about that – the need for physicians to ‘comfort always’ – an imperative one could easily believe overlooked if the previous day’s evidence from medics at the Australian and New Zealand Society of Palliative Medicine were any yardstick.

He catalogued eleven principles he believed should be taken into account when formulating how and when lawful provision of the drug should be effected – and they’re worth listing in full if only as a comparator with what in the end came about. Dr Wodak’s list therefore is as follows. For amusement each is accompanied by a tick or a cross using the blessed 20/20 vision of hind-sight.

1) National approach necessary to individual S&T approaches; X 2) Regulated preferable to unregulated; Tick3) Start slowly build incrementally as warrants (‘the more restrictive the approach adopted the larger the proportion of patients who will utilise unregulated supplies); Tick – possibly 4) Should be flexible; Tick – possibly5) Those involved should have no legal concerns; X6) The system established for medicinal cannabis should identify approved medical conditions and may also identify required diagnostic criteria and criteria indicating sufficient severity; Tick/X depending on S&T7) Scope for allowing use on (unspecified but) compassionate grounds; X8) Discussions should be by medical experts not Ministers, Officials or MPs; X9) Lawful cultivation should be an option but not the only option; X10) Affordability important; X/Tick awaiting outcome11) Eleventh, the least-worst way of ingestion at present is inhalation of cannabis vapour. Nabiximols—otherwise known as Sativex—the next best option, is currently approved in Australia for only one condition. In reality, it is unavailable and expensive. The older pharmaceutical preparations Nabilone and Marinol, now obsolete, were too poorly and erratically absorbed to succeed commercially. Administration by inhalation of smoke may sometimes have to be tolerated; X

Four out of eleven. Maybe. So much for that presentation. So much for those 30-odd years in the field.

Mr Mostyn brought a legal-academic and criminological perspective . In his view, the evidence was clear cannabis was a useful medication though in many respects so different from other drugs, the TGA would he said, struggle to manage it.

In his view, the proposed new Regulator would need only 15 years to help introduce the ‘new’ medicine, by which time things would be more certain, but noted not only was cannabis markedly different from conventional medicines but the evidence was rapidly changing because of obstacles to research in most parts of the world. ‘I think the nervousness that some people in the community have about this—and there are some people who are nervous about it—would dissipate over time, and people would see that this is not some horrible new monster that we are allowing in but that it is a useful drug for some people but it is not a panacea either—it is not going to end unemployment or anything else! Not a magical drug that cures everything,’ he told the Hearing, adding all doctors should be able to prescribe it.

The Bill was necessary, Mr Mostyn said, first because of the Therapeutic Goods Act and second the criminality of possession – two issues that continue to go unresolved despite passage and implementation, nearly 18 months later, of the Narcotic Drugs Amendment Act which of course replaced the Bill.

‘We’re essentially a group that says, ‘If it’s got some benefit then let’s use it, but we have always to make sure that the benefits outweigh the risks,’ offered Professor Morris, with a caveat now predictable from organisations such as his own: ‘The thing is that, unfortunately, the area has not been well developed, from the medical research perspective, in terms of trials and the sorts of things that would are put forward with any other medication that was being proposed for the treatment of various maladies. So there are some limitations in the information available. A lot of it is more anecdotal than would be the case with regular drugs that come up for scrutiny and for approval,’

Yes, yes. We know. Next you’ll be telling us it sends you mad.

‘The problem is that we know that cannabis causes substantial problems for people. These can be mild in terms of the effect of being sedated if you use the drug et cetera. But it can be much more serious, and concerns memory impairment, which can be clinically significant in individuals. The other thing is that there is a connection between cannabis use and the development in later life of serious mental illness such as schizophrenia,’ said Professor Morris, confident in the fact that vast research has been carried and resources spent on the harmful effects of the drug.

The College, was, he reported, saying: ‘Let’s have a look at this, but it should go through the regulatory process that any other medicine that is being used for medical conditions should go through. In Australia that is the Therapeutic Goods Administration.’

Despite his professed engagement with clinical traditions of the orient he too thought ‘cannabis needs to be seen much more clearly as a medication with potential benefits perhaps but also real potential harm if it is not regulated appropriately and with the degree of rigour that other medications face,’ adding it would be much more confidently used by the medical profession if it had been approved ‘through the process of the TGA’. Any other way of approval would, naturally, compromise standards and confidence in the approval process and therefore also drug’s safety of use.

So the Bill was a no-no for them.

Sen. Di Natale had a few questions. ‘Why should we rely on the TGA as a mechanism when it has clearly failed to date? The consequence of that is we have already got people using an unregulated drug in ways that may be harmful out in the community‘.

‘You are going to be asking doctors to prescribe this medication for certain conditions. Once you start doing that, the physicians that are doing this need to know that the medication has been appropriately approved and that the pros and cons and the safety versus effectiveness in that particular condition have been assessed adequately. Anything less than that means that basically you are using a form of regulation which does not meet the usual medical standards. For that you need the TGA experience‘.

Sen Di Natale did not agree. What followed was a debate in which the Royal Physicians conceded a new body might be necessary – and of course new one did come about, the Office of Drug Control. Not to look after the medical aspects of the drug you understand – the TGA will do that – but its cultivation and that sort of thing. And the Catch-22 in terms of getting the drug to the market remains a huge problem, as it will be for some time to come.

‘We believe, said Ms Callaghan, ‘elements of the bill set in place appropriate mechanisms to establish a scheme that enables safe access to medical cannabis for people who require it’.

‘I see this (proposed) Regulator as a body to be able to allow medications such as raw cannabis leaf, for example, to be transported across borders so that it can be standardised for research purposes. I see this as a regulator who will be able to say, ‘This is how much THC or CBD this drug has,’ and we are able to test it appropriately. That is where I see this regulator and its role to be important‘.

A fruitful discussion followed, including mention of an Australian study among end-of-life patients who were treated with antidepressants to help with their mood and well-being. The trial was stopped though because those on the antidepressant died earlier than those who were not.

Which is one way of fixing the problem.

One of the group – Professor Richard Chye, a network director of palliative care within Sydney, had spoken to patients who’d used cannabis.

‘I questioned them very carefully,’ said Prof Chye. ‘Did it help your pain? Did it help your nausea? After very close questioning, the answers that came back were that it helped them forget that they had difficulties. I tell them I am happy for them to use it on that basis. ‘Do not expect it to improve your pain. Do not expect it to improve your nausea. Only use it for the effect of making you feel a bit happier, but do not expect it to improve your pain. Still use the medications that I have prescribed for pain.’ It does not replace the morphine if it is severe pain or the other nausea medications. It does not replace that.’

It had been a long and mostly encouraging session, inspiring the Chair to remark: ‘I think parliament, reflecting the general public, is generally supportive of this whole thing, but we have to work out how to do it. That is important‘.

But there was the rub.

‘We just need to bring Solomon back and all will be well,’ he said, adjourning the day.

Where was his wisdom though when the Government cooked up its alternative?